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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 5MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005025X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82219391 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a 5mmx 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm). As a result, the saber pta balloon catheter was removed and a 5mm x 20cm non-cordis balloon catheter was successfully used to complete the procedure. There was no reported injury to the patient. This was during a procedure to treat arteriosclerosis obliterans in the superficial femoral artery (sfa). The lesion in the sfa was reported as a long segment stenosis of 90% which was confirmed to be a functional chronic total occlusion (cto). There was calcium present at the target lesion; however, there were no signs of tortuosity to the sfa. The device was prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components. The device maintained negative pressure during preparation and there were no kinks or observed damages noted prior to insertion. A non-cordis. 018 guidewire was used for the procedure. There were no damages observed on the. 018 guidewire and the wire was successfully delivered to the lesion followed by the insertion of the saber pta balloon catheter. There were no difficulties experienced while inserting the saber pta into the patient, and the device was able to successfully cross the sfa lesion. A non-cordis inflation device was used for the procedure and was prepared with 1:1 contrast to saline mixture. The saber pta was able to be removed easily from the patient and remained in one piece during removal, and the device will be returned for evaluation.
 
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Brand NameSABER 5MM25CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key13863450
MDR Text Key291238575
Report Number9616099-2022-05476
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48005025X
Device Catalogue Number48005025X
Device Lot Number82219391
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1
Treatment
-5MM X 20CM BD ULTRAVERSE .018 BALLOON; -DEMAX PRESSURE PUMP INFLATION DEVICE; -POCO V18 GUIDE WIRE
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